Merck Painkiller May Compete with Monsanto Drug
David Shook
04/23/1999
KRTBN Knight-Ridder Tribune Business News: The Record, Hackensack, N.J.
Merck & Co. is poised to begin marketing its new prescription analgesic, Vioxx , for the treatment of acute pain and arthritis, pending approval from the Food and Drug Administration.
But analysts, doctors, and Merck, of Whitehouse Station, still are split on how and where the drug will fit in the overall painkiller market.
Vioxx , which received a preliminary recommendation this week from the FDA's Arthritis Advisory Committee, would compete with Monsanto's Celebrex in the multibillion-dollar market for treating acute pain caused by arthritis, menstrual cramps, or dental or orthopedic surgery.
The advisory panel's recommendation sets up a potential drug marketing war between the makers of the two so-called superaspirins.
Celebrex, which debuted in January and received approval solely for arthritic pain, and Vioxx are known as cox-2 inhibitors, a new class of anti-inflammatory medicines considered safer than ibuprofen, naproxen, and other commonly prescribed non-steroidal drugs, called NSAIDs.
Cox-2 inhibitors supposedly cause fewer ulcers, less stomach bleeding, and other gastrointestinal problems than NSAIDs because they block the inflammatory enzyme cyclooxygenase. Aspirin and similar anti-inflammatory drugs do that, too, but they also block the cox-1 enzyme that protects the stomach lining.
For that reason, cox-2 drugs are expected to become big moneymakers in the prescription-strength painkiller market.
Already, 2.5 million prescriptions for Celebrex have been dispensed in its first 13 weeks on the market, compared with the record 2.7 million prescriptions of Viagra, Pfizer's impotency drug, in its initial 13 weeks.
Hemant K. Shah, a drug industry stock analyst in Warren, said that even though Vioxx may receive wider FDA approval than Celebrex, Monsanto's drug will be the true breadwinner this year.
"It's too late" coming on to the market, he said of Vioxx . "Celebrex has gotten the dominant share."
Shah expects Celebrex to generate more than $1.5 billion in sales for Monsanto's G. D. Searle pharmaceuticals division in 1999. Assuming Vioxx receives approval this summer -- as anticipated -- the drug should generate $250 million to $400 million in sales for Merck, he said.
The strongest initial demand should come from patients in need of longer-term relief from hip- or knee-replacement surgery, osteoarthritis, rheumatoid arthritis, or wisdom tooth removal, said Rebecca Higbee, a Merck spokeswoman.
However, neither drug will compete with the over-the-counter NSAIDs such as Advil, Aleve, and Motrin, all of which are more readily available than prescription drugs for treating headaches, minor back pain, and other common ailments, Shah said. Patients seeking short-term pain relief won't choose to visit a doctor for a prescription painkiller when Advil is available in any drugstore aisle, he said.
Not all doctors agree.
Stephen Brenner, an Emerson physician who treats arthritis, said some patients have walked into his office asking for Celebrex because it is considered easier on the stomach and taken only once a day.
"That's much easier than taking eight to 10 over-the-counter pills a day," Brenner said.
He attributed much of that demand to a huge marketing drive by Monsanto that has gotten many patients to ask for Celebrex by name. He expects the same kind of demand for Vioxx .
"I also think Merck's drug will chomp into that [over-the-counter] market," Brenner said.
Although the cox-2 drugs are heralded for limiting the side effects associated with NSAIDs, there are safety concerns.
Celebrex has been cited in reports of 10 deaths and 11 gastrointestinal hemorrhages in its first three months on the market, according to Monsanto reports submitted to the FDA.
Monsanto's medical review of the 10 cases indicates no direct link between Celebrex usage and the reported deaths, the company said, and the FDA doesn't believe the drug poses a special risk relative to other painkillers.
Yet, the agency has said more research is needed before a conclusion can be reached on the relative safety of the cox-2 drugs.
One rheumatologist in Englewood, Richard Andron, said he hasn't witnessed any stomach bleeding in patients taking Celebrex.
"It's a good drug, and in the right hands with the right patient selection, it should prove to be safe and effective," Andron said.
If Vioxx is approved, Andron said, he would prescribe both drugs, depending on how each patient responds to them.
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